FDA.reportPublic FDA data

germstarNORO

Manufacturer
Soaptronic, LLC
Effective date
2020-05-12
Label type
HUMAN OTC DRUG LABEL
Version
11
Source
legacy-cache
Hydrated at
2026-08-01 23:30:53

Label at a glance#

ProductgermstarONE
Active ingredientALCOHOL
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Ethyl alcohol 63% (W/W)

OTC - PURPOSE SECTION

Purpose

Antiseptic

INDICATIONS & USAGE SECTION

Uses


Kills 99.99% of all disease causing germs on contact, and protects and restores moisture.

WARNINGS SECTION

Warnings
For external use only. Keep out of eyes. In case of eye contact immediately flush eyes with water. If irritation persists, get medical attention. If swallowed, contact physician. Flammable, keep away from heat or flames. Germstar Wipes are safe for most surfaces, however can be harmful to some. Test wipe on a non-conspicuous area if unsure.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

DOSAGE & ADMINISTRATION SECTION

Directions

Apply Germstar all over the surface of your hands and rub into skin until dry. Supervise children in the use of this product.

SPL UNCLASSIFIED SECTION

Other information

Germstar is non allergenic. Store at 20° to 25°C (68° to 77°F). May be harmful to some surfaces/materials.

INACTIVE INGREDIENT SECTION

Inactive ingredients

Water, Isopropanol, Emollient Complex, Fragrance

OTC - QUESTIONS SECTION

Questions?

Call Germstar at 1-800.327.2606

germstarONE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

germstarONEgermstarONE

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ALCOHOLACTIVE INGREDIENT3K9958V90M6
ALCOHOLACTIVE MOIETY3K9958V90M6
WATERINACTIVE INGREDIENT059QF0KO0R6

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57915-02057915-020-01, 57915-020-02, 57915-020-04

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
germstarONEETHYL ALCOHOLSoaptronic, LLCa6909a0f-de15-51e3-e053-2995a90ab34f2024-12-19WarningsExact identifier
ndc (package): 57915-020-02
ndc (package): 57915-020-01
ndc (package): 57915-020-04
ndc (product): 57915-020
ndc11 (package): 57915002002
ndc11 (package): 57915002001
ndc11 (package): 57915002004
a5efc4e4-2c72-7aa3-e053-2995a90ad54b7733bc43-835f-4c00-82dd-0af78a31a0ff2020-05-18WarningsExact identifier
spl set id: 7733bc43-835f-4c00-82dd-0af78a31a0ff

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.